Iron Bioavailability From Biofortified Orange-fleshed Sweet Potato

NCT03840031 | Completed

• 1 other identifier: SASHA-II
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 2

Brief Summary

To combat iron deficiency in Low and Middle-Income Countries, sustainable food-based solutions have to be implemented to serve populations, not only individuals. One solution is the introduction of iron biofortified staple crops on market level. Before market level introduction, the bioavailability of iron in the new biofortified Orange Fleshed Sweet Potato (OFSP) breed needs to be assessed. In this study the investigator compares the fractional and total iron absorption after extrinsic stable isotope labelling of the new biofortified high iron OFSP variety and a normal market level OFSP variety. The study is conducted in Malawian women of reproductive age with marginal iron status.

Conditions

Iron-deficiency; Iron Deficiency Anemia

Keywords

Biofortification; Orange fleshed sweet potato; Stable isotope studies

Outcome Measures

Primary Outcomes (2)

• Fractional iron absorption from both Orange Fleshed Sweet Potato varieties

  Proportion of stable isotope administered with test meals that has been incorporate into erythrocytes 14 days after completion of specific test meal feeding period

  Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.

• Total iron absorption from both Orange Fleshed Sweet Potato varieties

  Amount of iron absorbed (mg) from the labelled test meals

  Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.

Secondary Outcomes (2)

• Concentration of plasma ferritin level

  screening (-1), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)

• Concentration of plasma CRP level

  screening (-1), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)

Study Arms (2)

Orange Fleshed Sweet Potato High Iron

EXPERIMENTAL

Meal sequence B, OFSP High Fe

Other: High Fe OFSP meal labelled with Fe-58

Orange Fleshed Sweet Potato Control

ACTIVE COMPARATOR

Meal sequence A, OFSP control

Other: Control OFSP meal labelled with Fe-57

Interventions

High Fe OFSP meal labelled with Fe-58 OTHER

400 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days

Orange Fleshed Sweet Potato High Iron

Control OFSP meal labelled with Fe-57 OTHER

400 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days

Orange Fleshed Sweet Potato Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Based on health passport or birth certificate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Woman aged 18-35 years old
• low/marginal iron status respectively evidenced by one of the following criteria: PF ≤ 25 µg/L
• Normal BMI for age (18.5-25.0 kg/m2)
• Weight less than 65 kg. A maximum weight limitation is needed since the stable isotope portions are based on body weight. We want to give equal amounts of stable isotopes to each study participant and therefore need to standardize body weight.
• Living in a study radius of 30 km from the meal distribution/ health centre side
• Willing and able to commute to the set meal distribution/ health centre side
• Able to understand and to sign\* written concept prior to trial entry
• Informed consent signed \* Signing of informed consent by either autograph or finger print.

You may not qualify if:

• Severe anaemia Hb \<80 g/l
• High infection rate based on CRP \> 5 mg/L
• Any known chronic diseases
• Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, as determined by the screening visit and by self-report from the subjects.
• Diagnosed food allergy.
• Pregnancy (urine test during screening
• Lactation.
• History of cancer within the past year, from self-report by the woman or as obtained from her health passport
• Any medication or supplement which may impact erythrocytes, Hb or haematocrit (to the opinion of the investigator).
• Iron supplementation therapy or perfusion in the last three months
• Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation or other cause influencing blood volume to be investigated by the PI)
• Have a high alcohol consumption (more than 2 drinks/day).
• Consumption of illicit drugs based on reported use (based on anamnesis only).
• Subject having a hierarchical link with the investigator or co-investigators.
• Fever (body temperature \>37.5 °C), on day 1 of the feeding scheme

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• University of Malawi: collaborator

Study Sites (2)

Training and Research Unit of Excellence, University of Malawi

Zomba, Malawi

Location

Swiss Federal Institute of Technology, Laboratory of Human Nutrition

Zurich, Canton of Zurich, 8092, Switzerland

Location

Related Publications (1)

• Jongstra R, Mwangi MN, Burgos G, Zeder C, Low JW, Mzembe G, Liria R, Penny M, Andrade MI, Fairweather-Tait S, Zum Felde T, Campos H, Phiri KS, Zimmermann MB, Wegmuller R. Iron Absorption from Iron-Biofortified Sweetpotato Is Higher Than Regular Sweetpotato in Malawian Women while Iron Absorption from Regular and Iron-Biofortified Potatoes Is High in Peruvian Women. J Nutr. 2020 Dec 10;150(12):3094-3102. doi: 10.1093/jn/nxaa267.

  PMID: 33188398 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michael Zimmermann, Prof.

  Swiss Federal Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant is blinded, meal option A --\> B or B --\> A based on investigator randomisation.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each woman consumes both Orange Fleshed Sweet Potato varieties

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: March 25, 2019
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); MA (1)